Rituximab biosimilar CT-P10 for the treatment of rheumatoid arthritis

ABSTRACT

Introduction: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by long-standing inflammation in multiple joints. Rituximab, a monoclonal antibody, which binds to CD20, is effective in suppressing disease activity and preventing joint damage in RA. CT-P10 was developed as a biosimilar of rituximab and approved for use to treat hematologic malignancies and immune diseases including RA.

Area covered: This article describes the need for this biosimilar and summarizes the non-clinical studies verifying the physicochemical and biologic similarities and the clinical studies confirming the clinical similarity of CT-P10 to rituximab in patients with RA.

Expert opinion: CT-P10 had been evaluated and proven the efficacy and safety in RA in Phase I and III randomized controlled trial with extension studies including a switching regimen. Therefore, CT-P10 is recommended in the treatment of RA.

KEYWORDS:

• Biosimilar
• CT-P10
• rheumatoid arthritis
• rituximab

Article Highlights

• Rituximab, a monoclonal antibody to the CD20, is used in rheumatoid arthritis (RA), non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

• CT-P10 was developed as a biosimilar of rituximab.

• CT-P10 was proved the physicochemical and biological similarities to rituximab in non-clinical studies and in vivo study.

• CT-P10 showed the highly similar efficacy and safety in treatment of RA from phase I and III randomized clinical trials.

• The extension study of CT-P10 in RA confirmed that switching regimen resulted in no difference in disease activity or adverse events.

Box 1. Drug summary box

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Declaration of interest

C-H Suh has received consulting fees from Celltrion. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One of the reviewers of this paper has participated in research leading to the registration of both GP2013 and CTP-10. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI16C0992).